Imagine working for a truly global firm whose employees share a singular passion - to make the world a better place. Our client is a global company whose employees enjoy what they do. They are driven by a set of values and a common purpose - to improve the world we live in. Innovation is built into every project that they manage and every community they serve.
1) Prepare regulatory submissions to ensure compliance with FDA and international regulations and guidelines at the guidance of the Regulatory Affairs Director
2) Assist Regulatory Affairs Director with preparation of regulatory documents including but not limited to annual reports, safety reports, IND amendments, FDA communications, etc.
3) Interact with all departments to co-ordinate preparation of and obtain necessary information for regulatory submissions
4) Maintain and update regulatory files and database (both electronic and paper copy), logs and saves all IND amendments
5) Provide QC review of data and reports that will be incorporated into regulatory submissions to ensure scientific accuracy and clarity of presentation
6) Write or update regulatory Standard Operating Procedures (SOPs) and working guidelines
7) Meet general day-to-day administrative needs of the Regulatory Department
8) Provide regulatory support to clinical, preclinical, CMC departments as needed
9) Assist in pharmacovigilance related regulatory activities
10) Assist in the supervision of global regulatory activities related to the start-up and conduct of a global phase 3 study at the guidance of the Regulatory Affairs Director
11) Assist Regulatory Affairs Director as needed
More questions? Want to know the Salary range? Keep reading.
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1) University degree is required (preference will be given to those with degree in relevant field, though all candidates are welcome and encouraged to apply)
2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
3) Recent experience in the biopharmaceutical industry is strongly preferred
4) Preference will be given to people who have recent experience in regulatory affairs
This is an amazing opportunity for someone who isn't afraid of rolling up their sleeves to get things done and has a great attitude. Our client believes in adding value to each and every thing they do and are looking for someone with similar values.
Sterling-Hoffman Life Sciences is the premier recruitment firm in North America for companies involved in the research, clinical development, manufacturing and distribution of drugs and devices that allow patients to live healthier and more fulfilling lives. Leveraging a network of relationships in every major city – including New York, San Francisco, Raleigh-Durham, Chicago, Dallas, Denver and Los Angeles – Sterling-Hoffman Life Sciences is ideally positioned to assist fast growing CROs, pharmaceutical companies, biotech firms and medical device players in their quest to recruit the best people.